Z-2530-2018Class III

Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000

Name: Z-2530-2018 Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000
Creator: Human Design Medical Llc
Published: 2018-05-08
License: https://open.fda.gov/license/

Breas Medical AB / initiated 2018-05-08 / Terminated / root cause: manufacturing process

FDA source

Human Design Medical Llc began a recall of Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals... on 2018-05-08. FDA classified it as Class III and gives the reason as "Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2530-2018
Classification: Class III
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-07-23
Terminated: 2020-05-04
Recalling firm: Breas Medical AB
Product: Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Product code: NOU Continuous, Ventilator, Home Use
Reason for recall: Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 8, 2018, the firm notified all affected customers via phone to quarantine all affected devices. On May 18, 2018, formal Field Safety Corrective Action letters were sent to all affected customers via FedEx. Customers were asked to remove affected units from use and return to the firm, and to complete and return the Acknowledgement and Product Replacement forms. Customers were informed that the firm would be shipping replacement devices.
Quantity in commerce: 45
Distribution: US Nationwide Distribution in the states of CA, FL, GA, MI, SC, and TX.
Product codes and lots: Pending

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2530-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2530-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-23

Product code NOU

K160481Class IIVivo 60Breas Medical AB / cleared 2016-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)